key: cord-0933129-kdf654z4
authors: Aarons, Derrick
title: Research in epidemic and emergency situations: A model for collaboration and expediting ethics review in two Caribbean countries
date: 2017-07-28
journal: Dev World Bioeth
DOI: 10.1111/dewb.12157
sha: a95e3a09d229a35ff2189682c618cff5add85e4a
doc_id: 933129
cord_uid: kdf654z4

Various forms of research are essential in emergency, disaster and disease outbreak situations, but challenges exist including the long length of time it takes to get research proposals approved. Consequently, it would be very advantageous to have an acceptable model for efficient coordination and communication between and among research ethics committees/IRBs and ministries of health, and templates for expediting (done with speed and efficiency) ethical review of research proposals in emergency and epidemic situations to be used across the Caribbean and in other low and middle income countries. This project involved a literature search and the interviewing of ministry of health officials, public health practitioners, and research ethics committee/IRB members in Jamaica and St. Lucia, to obtain suggestions for the best model for efficient coordination and communication between research ethics committees (RECs), and developed a template for expediting review of research protocols in epidemic and emergency conditions.

AARONS within a country has to undergo preparations in order to function. We saw examples of this during the 2014 -2016 Ebola virus epidemic in parts of Africa, and the chikungunya virus infection that caused much morbidity in all countries of the Caribbean. We are now witnessing a wave of zika infection with its severe adverse neurological effects in some foetuses and neurotropic effects in some adults.

Research during these situations could be invaluable, and sometimes has highly beneficial outcomes that include preventive vaccines and speedy treatment to minimize harm. As new and emerging epidemic infections are now occurring regularly in the global village, perhaps a permanent committee in each country that is prepared to address matters of research may be one solution to the current challenges for research in epidemic and emergency situations. The aim should be to minimize harm by saving lives as well as the efficient use of all resources.

Various forms of research are essential in outbreak situations, but procedural challenges such as the long length of time to get research proposals approved present a perennial problem worldwide. 5 In addition, at the Global Forum on Bioethics in Research that discussed emerging epidemic infections (November 2015) , there were repeated calls by various presenters regarding the need for collaboration between various research ethics committees (RECs/IRBs), particularly in epidemic situations. A standardized application form and a template for the ethical review of research proposals in emergency situations therefore needed to be developed, as well as models for collaboration between various research ethics committees in epidemic situations, especially when multi-centre studies are proposed. This could possibly expedite the conducting of research in public health emergencies, and facilitate the rapid sharing of research outcome data that could be highly beneficial not only to local communities, but also to the global community.

In light of all this therefore, the author utilized the knowledge and expertise existing within the Caribbean to produce templates that can facilitate the rapid conducting of research during epidemic or emergency conditions.

This project was not conducted as a research project, and so no formal research protocol was written and submitted to a research ethics committee. A literature search was conducted on RECs/IRBs and their procedures in emergency situations in the Caribbean and worldwide, to ascertain whether any prior guidance existed for how RECs should deal with research in emergency and epidemic situations.

As the largest English-speaking Caribbean country (and situated in the western Caribbean), Jamaica has four (4) functioning research ethics committees and so the Chairs of the 4 RECs were identified as key informants. Other key informants were public health officials in the Jamaican Ministry of Health and a major researcher who also serves on the largest research ethics committee on the island. The Organization of Eastern Caribbean States (OECS) comprise 9 small island countries with St. Lucia being the centre of its governance, and so the latter country was identified as being representative of the smaller islands of the Caribbean for this project. Key informants were identified at St. Lucia's Ministry of Health and from its research ethics committee.

Nine persons were interviewed in Jamaica, and eight persons in St. Lucia. The persons were specifically selected to be interviewed because of their work positions, knowledge of the subject area and experience -to be able to contribute to the knowledge and perspectives being sought. Interviews began with a preamble regarding emerging epidemic infections and the need for research during these epidemics, followed by specific questions.

Eight main questions were asked, and individual responses were subsequently evaluated. The individual responses to each question were tabulated, and those that made the same points in common (coding) were written up. Other individual responses that were not proffered by other respondents were also evaluated for their pertinence in answering the question posed. Those that were pertinent were also included to provide a comprehensive response (collated answer) to each question (see Results).

Further, among the many issues discussed at a retreat workshop of the REC of the Caribbean Public Health Agency (CARPHA) in February 2016 were the components of what would be required for any submission to the committee for research in emergency situations. 6 That REC is the regional research ethics committee serving its 24 member states in the Caribbean. One outcome of the workshop was their recommendations for the most important subject headings in an application form for research in emergency situations, and guidelines for the content of such research proposals.

All recommendations and data obtained were used to derive the standard application form to research ethics committees/IRBs for research in epidemic or emergency conditions, and a template for communication and collaboration between research ethics committees. Another study examined IRB members' experience in reviewing research protocols using emergency exception from informed consent, and found that those protocols took longer to review than other protocols. 24 Another reviewing the ethical guidelines related to research in disaster settings concluded that some concepts and terms identified in analyzed guidelines were used in an inconsistent manner and applied in different contexts. 25 

Bureaucracy, caution, and legal issues provide parameters, and may cause delays in the matter. Rules and guidelines will therefore be necessary to guide the process. A specific template should exist which would be activated during an emergency or epidemic infection.

Research ethics committees should be made aware of these special needs (for research in emergency and epidemic infections).

Whilst collaboration between research ethics committees is possible, hubris is likely to be an issue as each research ethics committee would not wish to regard itself as being subservient to another, or to give up control over its current areas of jurisdiction. There is currently no structure that connects one research ethics committee with another in Jamaica. Whist that at the Ministry of Health in Jamaica should function at the 'national' level, not all research proposals submitted to it can be evaluated and processed quickly, and there are significant delays in assessing protocols and so some research applicants actually begin their research before approval is given.

Perhaps an ad-hoc committee, comprising representatives from all stakeholders that would meet quarterly to plan for its possible response in emergency and epidemic situations.

Decisions made would be communicated back to the respective research ethics committees via their representatives on the ad-hoc committee. Legal backing would also be needed for this committee.

Collated answer -question 3:

No one committee knows what the other is doing, and so how does one know how they would behave in an emergency situation?

Competing universities will have 'competing' research ethics committees, which may also function under different institutional factors, rules, and cultural issues. There may also be political considerations. There is no system now for collaboration, and research ethics committees may not be knowledgeable about each other and each other abilities and competencies. Questions such as 'who decides there is an emergency' is also important. Consequently, a Terms of Reference would be needed, particularly for emergency situations.

Impediments could be addressed and removed in specially constituted meetings. As each committee wishes recognition for their areas of authority, each would be asked to articulate what they perceive to be impediments to their collaborating on the evaluation of research proposals. Mutual respect between research ethics committees would also have to be fostered for the work that they do. Thus concerns could be met in order to reach consensus. Getting to know each other and how each committee handles research proposals will inspire confidence and respect for each other.

In the medium to long term, Jamaica needs legislation for research with human participants, as what ought to occur can be stipulated in the legislation. Any alternative to legislation would have to be by force or by threat. Researchers should not perceive the process as a 'stumbling block.' There should also be a master list of contacts and addresses of all research ethics committees, which would be circulated to all of them.

A focal point involving a secretariat would also be good, and there should be a formal process involved. Regular reporting should also be a part of the process.

Also, one could commence an institutional framework with a meeting involving representatives (or Chairs) of all the research ethics committees, conceiving a Terms of Reference, and then proceeding from there. Currently there is no interaction between the various research ethics committees in Jamaica. Each representative would then lobby their own committee or institution.

committee?

Both answer A and B were chosen as the better model for decision-making for approval of a research project in emergency and epidemic situations. For A, the reasons given included the reality that this is what in fact happens. In this case, RECs should follow a template and simply pay attention to 'red flags' as they occur. Institutional politics dictates that none will allow another committee to determine issues of research approval for them. Another rationale is that not all the committees are equal in expertise and training, and so individual committees prefer to make their own decisions based on their own standards.

For choice B, the reasons given were for a special committee that would be constituted for emergency research approval only, and would meet perhaps on a quarterly basis. To achieve more, its composition should be small, e.g. 6-7 persons. These representatives would be 'high-powered' persons who would make decisions on behalf of their own institutions. Another rationale is that timeframe would be greatly reduced for ethical review. The major issue though is that in an epidemic situation, there should be one committee. This committee would be activated under the auspices of the Ministry of Health, and function for emergency situations and epidemic infections only.

There was also a suggestion to have two committees doing the evaluation instead of one, and a secretariat would then inform all the other committees that the research had been approved by two (2) committees.

Collated answer -question 7:

If the ethical review of research proposals in epidemic and emergency situations is to be done by one committee, that committee would have to be created, as the current ones are 'tarnished.' In an emergency, it might not be health-related alone, and so other ministries, etc., may also have to have representation. There needs to be a 'national' committee.

situations?

We need to have an emergency research ethics committee that is activated once an emergency occurs. Appropriate communication with the public will also be crucial, and a specific protocol for such Concurrent reviews of research proposals were also suggested, with corrections being done simultaneously by the pertinent committees. If the epidemic or emergency situation extends to regional involvement, then the ethical review could be conducted through the CARPHA REC.

If it is local to Jamaica, then it should really be the Ministry of Health, but their ethics committee currently is not efficient. The most efficient and effective way to collaborate research ethics review in epidemic and emergency situations will require for someone to take the lead, and to arrange for committees to meet and get things going. After the meetings, the discussions could be shared electronically. Patient/community representation should be a part of the discussions.

Another suggestion is for an emergency panel of suitable qualified persons to react to the urgency of the situation, and having representatives of the other committees serving on this emergency committee.

The Chairs and their secretariats should be involved. Training of admin secretariats should occur for them to recognize and respond appropriately in epidemic and emergency situations.

AARONS accept a review from another island, in order to expedite the research.

It would not need a full committee to review. The local ministry of health would have the responsibility to implement these suggestions and expeditious requirements, particularly when more than one research ethics committee function within its jurisdiction. The recommendations above would meet the WHO statement that flexible approaches are required to harmonize various review processes, and ensure that the various RECs can review the projects simultaneously and share and discuss the review outcomes with each other. 32

If the epidemic or emergency situation extends across country borders in the Caribbean region, then the ethical review could be conducted expeditiously through the regional research ethics committee provided by CARPHA.

This could involve an annual workshop for the Chairs of the various RECs in the region, at which the Chairs would discuss, fraternize, get comfortable with and get to know the background expertise of their counterparts and their committees. They would further discuss strategies to foster and support improved communication and collaboration between themselves. The chairpersons would have received the complete listings of all research ethics committees/IRBs existing in the region, so that they may contact any committee or committees they wish.

Collaborative work that involves developing country based research may be particularly helpful, especially when template documents are available. 33 The template developed for an application form to be used under the specified conditions addressed questions such as -What are the crucial details for inclusion in applications for research in emergency or epidemic situations? What are the standards to be met? What are research ethics committees looking for? This template is outlined in Appendix 1.

A template checklist for research ethics committees to use in evaluating proposed research in emergency or epidemic situations was also developed. The details of the recommended templates are to be found in Appendix 1.

As no guidelines or publication exist to advise RECs/IRBs regarding efficient and speedy communication and collaboration between themselves regarding proposed research in disaster, epidemic, or emergency conditions, this project has provided a model for so doing.

Where more than one REC exists in a country, an ad-hoc committee specific for addressing research in emergency and epidemic conditions is suggested, with representatives from the pertinent RECs, ministry of health, and affected communities. Legislative authority and other relevant support should be provided for the committee's functioning by the local ministry of health. A master list with contact details of all the RECs in the region should be available to the committee.

An annual workshop involving the chairs of all the REC in the region would aid in improving their communication and collaboration, particularly during regional epidemic conditions. The use of template documents by the RECs was also recommended. 

No conflicts declared. -Details of procedures to be performed (e. g. volume of blood, the frequency, timing, and possible site of the blood-taking; any drug administration, physiological measures, etc.) -Which procedures may cause pain and/or discomfort for research participants, which are new (i.e. experimental), and which are routine procedures that would have been done on the participants even if they were not involved in the study.

-Choice of participants, inclusion and exclusion criteria, number of participants (and a justification for that number), any controls, etc.

-A statement that participants were selected only because of the specific problem under investigation, and not because of their easy availability, diminished autonomy, or any social bias.

E. The name, address, telephone and email address of a contact person F. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed consent form to the participant or his/her legal guardian and will provide that person with a copy of the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he understands its content before the seeking of consent

A copy of the informed consent form and recruitment posters (see details below)

Methods to protect the confidentiality of participants, and methods to ensure that a participant who opts out of the research is well protected as far as health care delivery is concerned and not disadvantaged in any way. and significance of the Study (the potential value of the research for public health